Quality Assurance Specialist – Packaging Operations

About the role

We are seeking a Quality Assurance Specialist to join Bayer’s Pharmaceutical Affairs team in Berlin. The role focuses on supporting packaging operations for parenterals and solid dosage forms, managing deviations, and ensuring compliance with GMP standards.

Key responsibilities

• Oversee production lines in the packaging of parenterals and solids.
• Create and manage deviations, conduct root‑cause analyses and coordinate corrective actions with production and QA.
• Assess, lead and coordinate validation activities, including development of validation and testing plans.
• Draft and maintain SOPs related to qualification and validation.
• Prepare, complete and manage change requests within pharmaceutical affairs.
• Evaluate process flows from a regulatory perspective and implement compliance improvements.
• Contribute to the development of qualification and validation master plans.

Required profile

• University degree in pharmacy and a valid pharmacist’s licence.
• Strong knowledge of EU GMP guidelines and regulatory requirements.
• Excellent organizational abilities and meticulous work style.
• Assertive communication skills, both written and verbal.
• Resilient, flexible and able to work effectively in a team.
• Fluent German and good English language proficiency.

Required skills

• Proficiency with MS Office applications.

What we offer

• Competitive annual salary between €77,300 and €93,800 plus a variable component.
• Flexible benefits package tailored to personal needs.
• Company daycare centres and support for childcare.
• Time off for caring for elderly or dependent family members.